Clinical TrialSuicidalityKetaminePlaceboTerminated

Initiating Ketamine in Acutely Suicidal Patients in the Emergency Department

Randomised, parallel, placebo-controlled Phase III ED trial (n=62) testing a single IV ketamine infusion (0.5 mg/kg over 40 minutes) versus saline to reduce suicidal ideation in acutely suicidal military-affiliated adults.

Target Enrollment
62 participants
Study Type
Phase III interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomised, quadruple-masked, parallel-group trial in adults presenting to the emergency department with active suicidal ideation comparing a single 0.5 mg/kg IV ketamine infusion (100 ml NS over 40 minutes) versus 100 ml saline.

Primary outcome measures include the Beck Scale for Suicidal Ideation (BSSI) and MADRS-S assessed at baseline, 4 hours, 24 hours and one week post-infusion; secondary analyses include length of stay and safety/tolerability.

Rationale: ketamine’s rapid NMDA-antagonist effects may reduce suicidal ideation via increased synaptic plasticity and modulation of monoaminergic and glutamatergic systems.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Single IV infusion of ketamine 0.5 mg/kg in 100 ml normal saline over 40 minutes.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    0.5 mg/kg in 100 ml NS infused over 40 minutes; outcomes at 4h, 24h, and 1 week.

Saline

placebo

100 ml normal saline infusion over 40 minutes (placebo comparator).

Interventions

  • Placebo100 ml
    via IV• single dose• 1 doses total

    100 ml normal saline infused over 40 minutes (placebo).

Participants

Ages
18 – 89
Sexes
Male & Female

Inclusion Criteria

  • Patient demographics will consist of Active, Reserve, or retired military personnel or their dependents.
  • Inclusion criteria:
  • Adult (18 to 89 years old)
  • Present with active suicidal ideation
  • Deemed to be admitted to inpatient psychiatric unit

Exclusion Criteria

  • Exclusion criteria:
  • Age < 18 years or > 89 years
  • Currently presenting with psychosis as determined by mental health consultant
  • History of cognitive disorder that would impair understanding of consent
  • Personal or family history of schizophrenia
  • Currently pregnant or nursing
  • Serious and unstable medical condition/problems
  • Inability to medically clear
  • Non-English speakers
  • Civilian humanitarians
  • Previously enrolled in this study

Study Details

  • Status
    Terminated
  • Phase
    Phase III
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment62 participants
  • Timeline
    Start: 2020-01-14
    End: 2022-01-14
  • Compounds
    KetaminePlacebo
  • Topic
    Suicidality

Locations

Naval Medical Center Camp Lejeune — Marine Corps Base Camp Lejeune, North Carolina, United States

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